Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach

Abstract

Background Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the pipeline of clinical research nurse positions remains sparse. The International Association of Clinical Research Nurses’s (IACRN) strategic goal to “engage with nursing schools to heighten awareness and inclusion of the CRN role competencies in nursing education” prompted the development of an educational lecture module to be disseminated to nursing schools. This project is a pilot launch of the module. Methods A task force of IACRN was formed to develop educational materials that could be used as outreach to undergraduate nursing schools. The content included a slide presentation covering an overview of clinical research, the CRN practice, three embedded videos showing CRN and study participant perspectives, and coverage of the care of participants of research by staff nurses. Due to COVID-19 we revised our live lecture approach using either a live synchronous webinar presentation, or an embedded asynchronous course module with YouTube videos for course learning management systems. We presented the content to 408 nursing students attending three academic programs. To evaluate effectiveness and satisfaction, an anonymous, post-presentation survey using web-based QualtricsXM was distributed to students. Results Content and delivery of the module was positively evaluated. There was an improvement in knowledge in each topic. Evaluation responses showed that the content could likely or very likely improve care for their patients (87.4%) and improve patient education for patients in clinical trials (95%). Conclusions Delivering a synchronous or asynchronous module about the CRN practice role to nursing students in academic nursing programs is valuable to increasing awareness of the care of patients in clinical trials, the CRN role, and future professional development.

Embedding clinical research in pre-registration nursing and midwifery programmes

“…Despite an ever-increasing need for clinical research nurses and midwives across healthcare systems, career pathways in clinical research are rarely promoted by HEIs (Brand et al, 2022). This means many nursing and midwifery students have little understanding of what these roles involve (Capilli et al, 2022). Nursing and midwifery graduates who do have experience in conducting research are more likely to undertake further study and potentially embark on research roles throughout their careers (Menzies et al, 2021).…”

Navigating the challenges of clinical trial professionals in the healthcare sector

“…In this sense, the creation of the International Association of Clinical Research Nurses (IACRN) as a professional nursing organization dedicated to defining, validating, and advancing the specialty practice of clinical research nursing focused on “ maintaining the equilibrium between the care of the research participant and fidelity to the research protocol ” has been a breakthrough. The IACRN supports the professional development of CRNs with specific resources and meetings ( 110 ) and has created a curriculum for nursing school adoption and integration of research nursing within accredited programs ( 111 ). Oncology CRN has been considered a subspecialty ( 112 ), and some specific resources have been developed, such as the Manual for Clinical Trials Nursing ( 113 ), a description of their competencies ( 114 , 115 ), and a CTs Nurse Questionnaire used to determine the various activities of the CRNs within oncology ( 116 ).…”

“…Recent data indicate that the number of CRNs in the United States is decreasing ( 118 ), which is a matter of concern ( 119 ), considering that few nursing schools describe research nursing as a potential career ( 111 ). While it’s important for nurse professionals to conduct research ( 120 ), CRNs may face difficulties balancing regulatory compliance requirements, research integrity, recruitment targets, and eligibility criteria with their responsibility to prioritize the needs of research subjects and advocate for them.…”

“…The decentralization of CTs boosted by the COVID-19 pandemic implies a new model of working for nurses in CTs as home care is incorporated as standard practice. It implies that digital technologies are required, and updating nurses’ competencies is essential in this new CT deployment model, implying an added effort ( 111 ).…”